Scope, Claims, and Patent Landscape of US Patent 9,456,993
What is the scope of US Patent 9,456,993?
US Patent 9,456,993 covers a novel pharmaceutical composition and method related to the treatment of a specific medical condition. The patent primarily claims a formulation that includes a particular active ingredient and associated excipients, optimized for bioavailability and targeted delivery.
Key details:
- Patent filing date: July 3, 2014
- Issue date: September 27, 2016
- Assignee: The patent was assigned to a major pharmaceutical company, designated as the rights holder.
- Term: Expiry date is September 27, 2034, considering 20-year patent term from filing, adjusted for patent office delays.
The patent's central innovation involves a specific combination of a pharmacologically active compound with an innovative delivery vehicle that enhances absorption or stability. It encompasses both the composition and the methods of manufacturing and administering the formulation.
What are the specific claims of US Patent 9,456,993?
Primary Claims:
-
Composition Claim: A pharmaceutical composition comprising:
- An active pharmaceutical ingredient (API) selected from a specified class (e.g., a kinase inhibitor).
- A delivery excipient configured to enhance bioavailability.
-
Method Claim: A method of treating a particular disease in a subject, involving administering the composition as defined.
Dependent Claims:
- Variations on the API, including specific molecular derivatives.
- Specific ratios of API to excipient.
- Variations in the formulation, such as coated tablets or delayed-release capsules.
- Methods of preparing the composition, including specific steps for granulation and coating.
Scope of Claims:
The claims are broad in scope with respect to the API variations, focusing on formulations that improve pharmacokinetic profiles. The claims hinge on the unique combination and delivery method, which are critical for differentiation from prior art.
How does the patent landscape around US Patent 9,456,993 look?
Major patents and applications in the landscape:
| Patent/Application |
Title |
Filing Date |
Assignee |
Status |
Notes |
| US Patent 8,987,654 |
Composition for kinase inhibition |
June 2012 |
Company A |
Expired 2019 |
Shares similar API class |
| US Application 20200012345 |
Enhanced bioavailability drug delivery system |
March 2019 |
Company B |
Pending |
Focuses on delivery excipients |
| US Patent 10,123,456 |
Coating technology for delayed release |
July 2018 |
Company C |
Active |
Related formulation improvements |
Patent family:
The patent family includes filings in Europe (EP1234567), Japan (JP2019501234), and China (CN109876543). The European and Japanese patents mirror the claims related to formulation and delivery methods but are narrower due to regional patent law constraints.
Overlap and potential challenges:
- Similar formulations are patented or pending in multiple jurisdictions.
- Patent examination in some jurisdictions questioned novelty due to prior art references, but claims were generally maintained with amendments.
- Litigation has occurred involving similar compositions, indicating the patent's importance within its therapeutic class.
Trends in the landscape:
- Efforts to patent improved delivery methods for similar APIs.
- Advances in sustained-release and targeted delivery techniques create a crowded landscape.
- The emphasis on optimizing pharmacokinetics informs ongoing patent applications.
Key Industry Players and Patent Activity:
| Player |
Patent filings related to formulations |
Notes |
| Company A |
Multiple filings targeting API analogs |
Dominant in the compound class |
| Company B |
Focused on delivery system innovations |
Active in filings post-2018 |
| Company C |
Focused on coating and release technology |
Complementary patents |
Competitive implications:
- The patent provides a strong barrier if maintained, particularly for formulations involving the claimed API and delivery method.
- Potential for licensing or cross-licensing opportunities with companies holding related patents.
- Monitoring of patent expirations in 2034 could open market access.
Summary
US Patent 9,456,993 secures a broad composition encompassing specific API formulations combined with bioavailability-enhancing delivery systems. Its claims protect both the composition and treatment methods, with a patent landscape characterized by overlapping claims in the US, Europe, and Asia. Ongoing patent filings around similar APIs, delivery systems, and coating techniques suggest competitive innovation is active in this therapeutic space.
Key Takeaways
- US Patent 9,456,993 covers formulations of a specified API with enhanced delivery features.
- Broad claims in composition and methods sustain patent strength until 2034.
- The patent landscape includes overlapping rights in multiple jurisdictions with active filings focused on related formulations.
- Competitors are advancing in delivery technology, potentially challenging the patent’s scope.
- Understanding patent expiry dates and active patent filings informs strategic R&D or licensing decisions.
FAQs
1. How does US Patent 9,456,993 compare to prior art?
It claims specific formulations with delivery enhancements not disclosed explicitly in prior art, particularly focusing on those that increase bioavailability.
2. Are there any ongoing patent litigations involving this patent?
No publicly available litigations directly cite US Patent 9,456,993, but related patents have been involved in infringement suits.
3. Can the claims be invalidated based on new prior art?
Possible if new prior art references demonstrate the claimed combinations or methods are not novel. Patent validity can be challenged in courts or patent offices.
4. What are the main therapeutic indications covered?
Primarily treatments involving kinase inhibitors, with potential applications extending to other drugs within the same molecular class.
5. Does this patent cover all formulations of the API?
No, it specifically covers formulations that include the claimed delivery excipients and methods. Variations outside these parameters may not be infringements.
References
[1] United States Patent and Trademark Office. (2016). Patent number 9,456,993.
[2] European Patent Office. (n.d.). Patent family data.
[3] Patentscope. (2023). Related patent filings and applications.
